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Introduction
Published in Marcello Pagano, Kimberlee Gauvreau, Heather Mattie, Principles of Biostatistics, 2022
Marcello Pagano, Kimberlee Gauvreau, Heather Mattie
The study of statistics explores the collection, organization, analysis, and interpretation of numerical data. The concepts of statistics may be applied to a number of fields, including business, psychology, and agriculture. When focus is on the biological and health sciences, we use the term biostatistics.
Career Opportunities in Industrial Clinical Research
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
In clinical research, Statisticians will usually start at a staff level. Initially they will demonstrate their abilities in problem solving and in adaption of biostatistics to the development of clinical research protocols and to the proper statistical evaluation of the results of such studies. They will have opportunities for creative use of their knowledge, e.g., in refinement of techniques of sequential analysis or in techniques of retrospective case-control study.
Biotechnology industry
Published in Ronald P. Evens, Biotechnology, 2020
The Development Division takes on the product candidate from the research division to perform the clinical trials with patients with the target disease and establish its efficacy and safety (Figure 10.5). Clinical trials in humans progress from Phase 1 (with normal subjects for product activity and safety), to Phase 2 (in patients with target disease to document disease improvement, reasonable dosing schemes, safety), and metabolism (absorption-distribution-metabolism-elimination studies in normal subjects and patients), to Phase 3 (pivotal studies in target patients to establish safety and efficacy sufficient for product approval for marketing). The biostatistics group summarizes and analyses the data from the clinical trials for statistical reports. Project management coordinates and tracks all the studies and helps keep projects on time and on target in support of everyone else. Quality assurance is an internal audit function to ensure all the projects and reports are of the highest quality to ensure product approval by regulatory authorities. Resources may be limited as a candidate moves through the phases of research, creating the need to outsource a function to a vendor with the requisite expertise, usually called a contract research organization (CRO). Clinical data from the patient trials with the accompanying clinical trial reports are the outcomes from the Development Division.
Measurement Invariance of Psychological Distress, Substance Use, and Adult Social Support across Race/Ethnicity and Sex among Sexual Minority Youth
Published in The Journal of Sex Research, 2023
It is important to note that the health inequities experienced by sexual minority youth do not stem from the identities themselves but from the policies and practices that disadvantage sexual minority youth. Past research on sexual minority youth health does not consistently differentiate between identity and the social processes that generate inequities (Bauer, 2014). This failure implicitly frames health disparities as inherent and intractable. Further, methodological paradigms rooted in biostatistics and guided by notions of risk attached to particular identities (Bauer, 2014) limit the capacity of public health methods to investigate health at the nexus of multiple, intersecting identities (Bowleg, 2021; Bowleg & Bauer, 2016). Intersectional research understands that identities are proxies for the social processes that create, heighten, or diminish inequities (Aguayo-Romero, 2021).
Use of Routinely Collected Registry Data for Undergraduate and Postgraduate Medical Education in Denmark
Published in Journal of European CME, 2021
Kasper Bonnesen, Cecilia Hvitfeldt Fuglsang, Søren Korsgaard, Katrine Hjuler Lund, Natascha Gaster, Vera Ehrenstein, Morten Schmidt
During the Bachelor’s program, medical students enrol in the compulsory course “Epidemiology and Biostatistics” [30]. This 10 European Credit Transfer and Accumulation System (ECTS) course, offered during the fourth semester, covers the fundamentals of statistical and epidemiological principles and methods to enable understanding and critical evaluation of peer-reviewed reports of epidemiologic studies. Key theoretical topics covered in the course include epidemiological study designs and measures of occurrence and association; basics of causal inference including common sources of confounding and other biases; and special clinical topics, such as properties of diagnostic tests. Biostatistics topics include the main type of descriptive and inferential analyses (expected values, stratification, standardisation, and regression-based methods) [38]. Medical students may be offered to read and critically evaluate epidemiological studies as the first-time acquaintance with registry data. The course explicitly prepares medical students for the fifth-semester elective Bachelor’s project and the subsequent compulsory course in public health.
Comparative randomized study on the sexual function and quality of life of women on contraceptive vaginal ring containing ethinylestradiol/etonogestrel 3.47/11.00mg or 2.7/11.7mg
Published in Gynecological Endocrinology, 2019
Salvatore Caruso, Marco Panella, Giuliana Giunta, Maria Grazia Matarazzo, Antonio Cianci
ANOVA was used to compare the demographic and clinical data between the two groups. Paired Student’s t test was used to compare the within group values obtained at baseline with those of follow-ups from the FSDS, SF-36 domains and VAS. For comparisons of the intragroup values obtained from the FSFI items between baseline and both the follow-ups, the nonparametric Wilcoxon rank-sum test was used; and to compare the intergroup FSFI scores, the Mann-Whitney U-test was used. Scores are presented as mean ± SD. Intention-to-treat analyses were performed for all efficacy variables with the last observation carried forward for patients who prematurely discontinued treatment. All women who had a baseline evaluation and at least one efficacy assessment after the baseline examination/interview were included in the analysis. The result was statistically significant when p < .05. Statistical analyses were carried out using the Primer of Biostatistics statistical computer package (Glantz SA, New York, USA: McGraw-Hill, Inc.1997).